Avamys
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
29-03-2022
Charakterystyka produktu
(SPC)
29-03-2022
Sprawozdanie z oceny publicznego
(PAR)
06-07-2009
Składnik aktywny:
fluticasone furoate
Dostępny od:
GlaxoSmithKline (Ireland) Limited
Kod ATC:
R01AD12
INN (International Nazwa):
fluticasone furoate
Grupa terapeutyczna:
Nasal preparations, Corticosteroids
Dziedzina terapeutyczna:
Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial
Wskazania:
Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.
Podsumowanie produktu:
Revision: 22
Status autoryzacji:
Authorised
Data autoryzacji:
2008-01-11
Ulotka dla pacjenta
20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVAMYS 27.5 MICROGRAMS PER SPRAY NASAL SPRAY SUSPENSION
fluticasone furoate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Never pass it on to
others. It may harm them, even
if their signs of illness seem the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What Avamys is and what it is used for
2.
What you need to know before you use Avamys
3.
How to use Avamys
4.
Possible side effects
5.
How to store Avamys
6.
Contents of the pack and other information
Step-by-step guide to using the nasal spray
1.
WHAT AVAMYS IS AND WHAT IT IS USED FOR
Avamys (fluticasone furoate) belongs to a group of medicines called
_glucocorticoids_. Avamys works to
decrease inflammation caused by allergy (_rhinitis_) and therefore
reduce symptoms of allergy.
Avamys nasal spray is used to treat symptoms of allergic rhinitis
including stuffy, runny or itchy nose,
sneezing and watery, itchy or red eyes, in adults and children aged 6
years and over.
Allergy symptoms can occur at specific times of the year and be caused
by allergy to pollen from grass or
trees (hayfever), or they can occur all year round and be caused by
allergy to animals, house-dust mites or
moulds to name some of the most common.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AVAMYS
DO NOT USE AVAMYS
•
IF YOU ARE ALLERGIC to fluticasone furoate or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
CHILDREN AND ADOLESCENTS
Do not use in children under 6 years old.
22
Taking Avamys:
•
may when taken for a long time cause children to grow more slowly. The
doctor will check y
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
AVAMYS 27.5 micrograms/spray, nasal spray suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each spray actuation delivers 27.5 micrograms of fluticasone furoate.
Excipient with known effect
One actuation delivers 8.25 micrograms of benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, suspension.
White suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Avamys is indicated in adults, adolescents and children (6 years and
over)
Avamys is indicated for the treatment of the symptoms of allergic
rhinitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents (12 years and over) _
The recommended starting dose is two spray actuations (27.5 micrograms
of fluticasone furoate per spray
actuation) in each nostril once daily (total daily dose, 110
micrograms).
Once adequate control of symptoms is achieved, dose reduction to one
spray actuation in each nostril
(total daily dose 55 micrograms) may be effective for maintenance.
The dose should be titrated to the lowest dose at which effective
control of symptoms is maintained.
_Children (6 to 11 years of age) _
The recommended starting dose is one spray actuation (27.5 micrograms
of fluticasone furoate per spray
actuation) in each nostril once daily (total daily dose, 55
micrograms).
Patients not adequately responding to one spray actuation in each
nostril once daily (total daily dose,
55 micrograms) may use two spray actuations in each nostril once daily
(total daily dose,
110 micrograms).
Once adequate control of symptoms is achieved, dose reduction to one
spray actuation in each nostril once
daily (total daily dose, 55 micrograms) is recommended.
3
For full therapeutic benefit regular, scheduled usage is recommended.
Onset of action has been observed
as early as 8 hours after initial administration. However, it may take
several days of treatment to achieve
maximum benefit, and the patient should be info
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